MEMORANDUM OF UNDERSTANDING BETWEEN
THE FOOD AND DRUG ADMINISTRATION
The United States Food and Drug Administration (FDA) and Stanford University (Stanford) share interests in promoting scientific progress through exchange of scientific capital in diverse fields of science that affect human and animal health and medicine. Both institutions foresee benefits from scientific training for academicians and students to foster a well-grounded foundation in interdisciplinary science on which scientific learning can grow. This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through a variety of programs including collaborative research, public outreach, extension activities, cooperative international initiatives, disciplinary training, and exchange of scientists and staff, including sabbaticals, postdoctoral fellowships, and student internships.
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act) as amended (21 U.S.C. 301, et seq.). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods, dietary supplements, and cosmetics. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships within Stanford University will greatly contribute to FDA’s mission.
Stanford University is recognized as one of the leading universities in the world. Multidisciplinary research and teaching are at the heart of Stanford’s initiatives on human health, the environment and sustainability, international affairs and the arts. The synthesis of teaching and research is fundamental to Stanford. Stanford is noted for multidisciplinary research within its schools and departments, as well as its independent laboratories, scientific centers and institutes.
III. Substance of Agreement:
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and Stanford. The types of initiatives expected to develop from this MOU include:
- Opportunity to apply for a joint fellowship program at the FDA to advance student education and matriculation into the health, biomedical and applied science professions. One of the mechanisms to enroll students/post-doctoral trainees/residents from Stanford into the joint fellowship program at the FDA may be through the CDER Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbatical may be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the ORISE fellowship program mechanism, the Office of Surveillance and Epidemiology and Stanford will adhere to the ORISE Fellowship rules and regulations. Fellows or faculty members entering the program must agree to adhere to the term of appointment which will be outlined in an offer of appointment letter;
- Opportunities for FDA staff to serve as adjunct faculty or on advisory boards;
- Opportunities to convene joint meetings for education and research;
- Research collaborations;
- Cooperative international initiatives; and
- Access to unique facilities and equipment for scientific endeavors.
- Under this MOU, joint efforts will be undertaken to support collaborative research and training as permitted under appropriate statutory authority. Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and develop separate, written agreements for collaboration and sharing of resources. Where applicable, these agreements shall incorporate by reference to this MOU. FDA may enter a contract, grant or cooperative agreement with Stanford University to the extent authorized by law and available appropriations. The terms and conditions of any such agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of institutions within Stanford and FDA.
IV. General Provisions
- Rights to any inventions resulting from collaborative research will be determined by the separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
- Institutions within Stanford and FDA may decide to enter into Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
- Proprietary and/or nonpublic information will not be disclosed under this MOU, unless such disclosure is governed by separate Confidentiality Disclosure Agreements in which the Partners will agree and certify in writing that they shall not further release, publish or disclose such information and that they shall protect such information in accordance with the provisions of 21 U.S.C. 331(j), 21 U.S.C. 360j(c), 18 U.S.C. 1905, and other pertinent laws and regulations governing the confidentiality of such information. No proprietary data, tradesecrets or patient confidential information shall be disclosed among the Partners unless permitted by applicable law.
- Each Party will comply with the other Party's security procedures and policies regarding access to and use of facilities. Either Party may restrict or limit access to its property and facilities at any time and for any reason. Stanford individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
- As research projects are developed, details will be agreed to in advance under other agreements as appropriate and in compliance with all applicable federal requirements.
V. Resource Obligations
This MOU represents the broad outline of the FDA and Stanford’s intent to collaborate in areas of mutual interest. All activities that may be undertaken by this MOU are subject to the availability of resources. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU. This MOU does not create binding, enforceable obligations against any Party.
VI. Liaison Officers:
A. For the Food and Drug Administration:
Gerald J. Dal Pan, MD MHS,
Food and Drug Administration
Acting Director, Office of Surveillance and Epidemiology
10903 New Hampshire Avenue
Silver Spring, MD 20993
Telephone Number: 301-796-2380
Carolyn A. Wilson, Ph.D.
Associate Director for Research
Center for Biologics Evaluation and Research
Food and Drug Administration
Building 29B, Room 5NN01
8800 Rockville Pike
Bethesda, MD 20892
Tel.: 301 827 0481
Fax: 301 827 3187
B. Stanford University
Nigam H. Shah, MBBS, PhD
Assistant Professor of Medicine (Biomedical Informatics)
450 Serra Mall, Stanford, CA 94305-2004
650-725-6236 (office); 650-725-7944 (fax)
Each Party may designate new liaisons at any time by notifying the other administrative liaison in writing. If, at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Party previously represented by that individual will name a new liaison within 2 weeks and notify the other through the designated administrative liaison.
VII. Terms, Termination and Modification:
This agreement will be effective when accepted by all participating partners. This agreement may be modified or terminated by mutual written consent by the partners or may be terminated by either Partner(s) upon a 60-day advance written notice to the other.
VIII. Statutes, Regulations, Rules, and Policies
This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA, Stanford and the institutions within Stanford University operate.
APPROVED AND ACCEPTED FOR STANFORD UNIVERSITY (California)
Signed by:Harry Greenberg, MD
APPROVED AND ACCEPTED FOR THE FOOD AND DRUG ADMINISTRATION
Signed by:Director, CDER/FDA